US regulators have granted temporary approval for the importation of a variant of penicillin used to treat syphilis due to a shortage of Pfizer Inc.’s version of the drug and a surge in syphilis cases. The Food and Drug Administration (FDA) has authorized the importation of penicillin G benzathine from French company Laboratoires Delbert, as Pfizer’s Bicillin L-A, the sole available version in the US, has faced shortages since April.
Penicillin G benzathine is the preferred treatment for syphilis and the only medication for the congenital form of the disease, which caused numerous fatalities among babies and fetuses in 2022. In response to the rising rates, a national task force was established to address the situation, described by the Chief Medical Officer of the Centers for Disease Control and Prevention as “heartbreaking.”
While a single injection of penicillin G benzathine can cure syphilis, the shortage led US health officials to recommend doxycycline, an alternative antibiotic therapy requiring weeks of twice-daily pills for some patients. This extended treatment regimen increases the risk of incomplete courses, leaving patients unwell and potentially infectious.
The FDA’s decision to allow the importation of Laboratoires Delbert’s penicillin G benzathine was praised by the National Coalition of STD Directors, expressing hope that it signals progress toward resolving the shortage. Pfizer, addressing the issue, has increased manufacturing shifts and reduced production time, aiming to alleviate the shortage, estimated to persist until June. The company encourages customers facing difficulties obtaining the drug to contact them directly, emphasizing their commitment to supplying the market at rates exceeding historical levels and reserving products for emergencies.
Unlike Pfizer’s prefilled syringe, the formulation of Laboratoires Delbert’s drug is a powder that requires mixing before administration by a healthcare provider.